Regulatory Affairs

vor 2 Wochen

Zurich, Schweiz Proclinical Vollzeit

Our client a global pharmaceutical company specializing in rare diseases, Nephrology and Cardiorenal therapeutic areas is looking to appoint a Regulatory Affairs Labelling manager in their Zurich offices. This is an excellent opportunity to gain global experience within RA labelling in a high performing team at a time when multiple new drug development programs are ongoing.

You will have significant experience within Regulatory Affairs in a pharmaceutical or biotechnology setting and exposure to labelling topics such as CCDS creation at the local or global level.

**Responsibilities**
- Oversee arrangements and operation of external solution providers supporting GRAL activities.
- Strategic Labelling.
- Support CCDS creation & update in collaboration with other line functions by providing strategic input related to CCDS impact on labelling.
- Leading GRA Labelling quality initiatives.
- Support for CCDS implementation into local labelling including planning of roll-outs and strategical implementation into the local SmPC, PIL and labelling based on local regulation and management of deviations
- Fulfil GRAL role and contribute to team activities as per mandated processes.
- Support for responding to Health Authority questions on product information-related issues.
- Interface with key stakeholders across the company.
- Operational Labelling & Packaging (all regions).
- Support and recommendations to GRA department and other departments on labelling related issues.
- Maintenance of specific product labelling related information in department databases, systems and external processes (e.g. PSMF, XEVMPD, GLS, eDMS) and relevant tracking and planning systems (Trackwise).
- Validation/record of product information documents, e.g. SmPC, PIL, packaging.

**Minimum Requirements**
- University degree in Life Sciences or Pharmaceutical related fields.
- Experience (5-8 years) working in regulatory affairs or supply chain specifically with labelling or packaging related responsibilities.
- Excellent command of English - both spoken and written.
- Expertise in the use of basic IT systems & tools.

**Preferred Requirements**
- Higher university degree (Masters) in a relevant life sciences discipline, or specialised degree (Pharmacist).
- Basic knowledge of drug development & labelling related issues.
- Experience in pharmaceutical packaging implementation.
- Familiarity with either pharmacovigilance concepts and practices, or with pharmaceutical supply chain processes.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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